This invention relates to utilizing a probiotic organism in a therapeutic composition, and specifically relates to the use of a lactic acid-producing bacteria, preferably Bacillus coagulans spores, for control and reduction of serum cholesterol.
Probiotic agents are organisms that confer a benefit when they grow in a particular environment, often by inhibiting the growth of other biological organisms in the same environment. Examples of probiotics include bacteria and bacteriophages which can grow in the intestine, at least temporarily, to displace or destroy pathogens and provide other benefits to the host organism (Salminen et al, Antonie Van Leeuwenhoek, 70 (2-4): 347-358, 1996; Elmer et al, JAMA, 275:870-876, 1996; Rafter, Scand. J. Gastroenterol., 30:497-502, 1995; Perdigon et al, J. Dairy Sci., 78:1597-1606, 1995; Gandi, Townsend Lett. Doctorsand Patients, pp. 108-110, January 1994; Lidbeck et al, Eur J. Cancer Prey. 1:341-353, 1992).
The therapeutic use of probiotic bacteria, especially Lactobacillus strains, that colonize the gut has been previously disclosed (Winberg et al, Pediatr, Nephrol, 7:509-514, 1993; Malin et al, Ann. Nutr. Metab. 40:137-145, 1996; and U.S. Pat. No. 5,176,911).
Lactic acid producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been used as food additives and there have been some claims that they provide nutritional and therapeutic value (Gorbach, Ann. Med. 22:37-41, 1990; Reid et al, Clin. Microbiol. Rev., 3:335-344, 1990).
Bacillus coagulans is a non-pathogenic gram positive spore-forming bacteria that produces L(+) lactic acid (dextrorotatory) in homofermentation conditions. It has been isolated from natural sources, such as heat-treated soil samples inoculated into nutrient medium (Bergey""s Manual of Systemic Bacteriology, Vol. 2, Sneath, P.H.A. et al., eds., Williams and Wilkins, Baltimore, Md., 1986). Purified B. coagulans strains have served as a source of enzymes including endonucleases (e.g., U.S. Pat. No. 5,200,336), amylase (U.S. Pat. No. 4,980,180), lactase (U.S. Pat. No. 4,323,651) and cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 5,102,800). B. coagulans has been used to produce lactic acid (U.S. Pat. No. 5,079,164). A strain of B. coagulans (referred to as L. sporogenes Sakaguti and Nakayama (ATCC 31284)) has been combined with other lactic acid producing bacteria and B. natto to produce a fermented food product from steamed soybeans (U.S. Pat. No. 4,110,477). B. coagulans strains have also been used as animal feeds additives for poultry and livestock to reduce disease and improve feed utilization and, therefore, to increase growth rate in the animals (International PCT Pat. Applications No. WO 9314187 and No. WO 9411492).
In particular, B. coagulans strains have been used to reduce serum cholesterol in certain formulations (Mohan et al, Indian J. Medical Research, 92:431-432, 1990), although this approach did not reduce triglycerides sufficiently and resulted in excessive reductions on xe2x80x9cgoodxe2x80x9d cholesterol, e.g., high density lipoprotein (HDL).
Supplementation of diet with fructo-oligosaccharides (FOS) have been reported to provide health benefits including reduction of serum triglycerides. Mitsuoka et al, Nutrition Research, 4:961-966, 1984.
However, there remains a need for control of cholesterol to treat cholesterol related diseases.
It has now been discovered that serum cholesterol can be controlled and reduced while maintaining or increasing HDL by use of a combination of active agents in a therapeutic composition that includes a non-pathogenic lactic acid producing bacteria, such as Bacillus coagulans, and a therapeutic agent selected from the group consisting of an effective amount of a cholesterol-reducing agent and a bifidogenic oligosaccharide.
According to a preferred embodiment of the invention, there is provided a composition comprising an isolated Bacillus coagulans strain in combination with an effective amount of a fructo-oligosaccharide (FOS) in a pharmaceutically acceptable carrier suitable for administration to the digestive track of a human. In one embodiment of the composition, the Bacillus coagulans strain is included in the composition in the form of spores. In another embodiment, the Bacillus coagulans strain is included in the composition in the form of a dried cell mass.
The invention also describes a method for decreasing serum cholesterol and increasing serum HDL in a patient comprising administering an effective amount of a composition comprising viable lactic acid-producing bacteria and a therapeutic agent selected from the group consisting of an effective amount of a cholesterol-reducing agent and a bifidogenic oligosaccharide. The composition may optionally include a cholic acid complexation agent such as a metal salt and the like.
The invention also describes a therapeutic system for reducing serum cholesterol comprising a container comprising a label and a composition as described herein, wherein said label comprises instructions for use of the composition for reduction of serum cholesterol.
It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.